# K100989: Zura Tee System with Claritee Probe

- Pathway: 510(k) (Traditional)
- Applicant: Imacor, Inc.
- Decided: Jun 25, 2010 after 77 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 88 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080223: Zura Tee System, Imacor, LLC (2008) Summary page 2.
- K083095: Sonixtouch Ultrasound System, Ultrasonix Medical Corporation (2008) Summary page 2.
- K042326: Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner, Ultrasonix Medical Corporation (2004) Summary page 2.

## Most influential descendants
- K142054: Imacor Zura Evo Imaging System (2014), 0 descendants of its own

## Recalls of this device
- Sep 16, 2024 · Class II · Z-0231-2025: Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained f

## Indications for use
The ImaCor Zura system with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura system with ClariTEE probe is not intended for pediatric use The ImaCor Zura system is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor system is not intended for pediatric use The ImaCor ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ClariTEE probe is not intended for pediatric use.

Source page: https://510kreport.com/device/K100989
Methodology: https://510kreport.com/methodology